非诺洛芬钙缓释片的研制及释药性质研究

为减少非诺洛芬钙（ｆｅｎｏｐｒｏｆｅｎｃａｌｃｉｕｍ）的胃肠道刺激性和副作用，根据水凝胶骨架释放机理，研制了非诺洛芬钙缓释片。通过测定制剂的体外溶出度评价了该缓释片的处方。结果表明该制剂的体外溶出行为符合Ｈｉｇｕｃｈｉ方程，释药常数（Ｋ）主要受原辅料比例的影响。不同处方的释药常数，５０％释药时间（Ｔ５０）和６３．２％释药时间（Ｔｄ）有显著差异（Ｐ＜０．０１）。处方５具有良好的缓释效果，其Ｔ５０和Ｔｄ分别为２８８ｍｉｎ和４３８ｍｉｎ。此外，溶出介质ｐＨ、转速及溶出试验方法对该制剂的释药速度常数也有影响。

Studies on Preparation and Release Properties on Slow Released Fenoprofen Calcium Tablets

To decrease the GI irritation and side effect of fenoprofen calcium, slow released tablets of fenoprofen calcium were prepared on the basis of the releasing mechanism of the gel matrix systems. The formulation and preparing procedure of the tablets were evaluated by the USP basket dissolution method. The results showed that the dissolution behavior of the tablets followed Higuchi kinetics. The release rate constants( K ) were effected by the ratio of drug and polymers. The K , 50% released time( T 50 ) and 63.2% released time( T d) were varied for different formulations. Formulation 5 had good slow release rate. Its T 50 and T d were 288 min and 438 min, respectively.